DALLAS, July 09, 2015 (GLOBE NEWSWIRE) -- Gradalis, Inc., a clinical-stage biopharmaceutical company, today announced the initiation of a Phase 2b study for its proprietary, personalized cancer vaccine, Vigil™, in the treatment of patients with Ewing’s sarcoma.
Patients with metastatic Ewing’s sarcoma Family of Tumors (ESFT) disease, deemed to be refractory or intolerant to at least two prior lines of chemotherapy, will be randomized 1:1 to receive either: (1) Vigil™ vaccine administered by standard intradermal injection once monthly for up to 12 months or (2) a standard of care intravenous chemotherapy regimen of gemcitabine combined with docetaxel.
The primary objective of the study is to determine the one-year survival rate of patients treated with Vigil™ versus gemcitabine/docetaxel. Patients will also be followed for clinical response rate as well as safety. Patients will be monitored for a tumor-specific immune response using sequential IFNγ-ELISPOT (immune activation) assay to detect activated cancer-targeting lymphocytes before and following treatment.
“We hope to demonstrate that Vigil™ is well tolerated, elicits a tumor-specific systemic immune response in patients, and leads to a favorable survival outcome,” said John Nemunaitis, M.D., Chief Medical Officer of Gradalis.
Gradalis is pursuing several other clinical targets for Vigil™, including ovarian cancer and multiple other solid tumors.
Vigil™ is a proprietary, personalized, immunotherapy platform developed by Gradalis. A patient’s tumor cells are engineered to elicit a systemic T-cell directed immune response when administered to the patient through intradermal injections. By utilizing the patient’s own tumor as the antigen source, Vigil™ is designed to elicit an immune response that is both specifically targeted and broadly relevant to each patient’s unique tumor antigens.
Gradalis is a fully integrated biotechnology company based in Dallas, Texas that focuses on the development, manufacturing, and commercialization of novel proprietary personalized immunotherapies to treat cancer. Gradalis operates a cGMP manufacturing facility in Carrolton, Texas. For more information about Gradalis, Inc. please visit www.gradalisinc.com.
Contact: Beth Kriegel Chief Financial Officer (214) 307-8203